FDA.reportPublic FDA data

Sterile Dispoable Endocavity Needle Guide

Primary DI
10841912101792
Brand
Sterile Dispoable Endocavity Needle Guide
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
9000
Catalog number
9000
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841912101792PackageGS124In Commercial Distribution
00841912101795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191210179210841912101792
00841912101795008419121017958419121017950841912101795

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965417181
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841912106049System Cover107410742020-11-06
10841912106490Sterile Protective Barrier Kit162416242020-06-01
10841912106506Sterile Protective Barrier Kit162816282020-06-01
10841912106513Sterile Protective Barrier Kit164816482020-06-01
10841912106520Sterile Protective Barrier Kit169616962020-06-01
00841912106691Reusable Biopsy Bracket62772020-11-13
00841912106745Biopsy Starter Kit72772020-11-13
10841912107107Sterile Disposable Endocavity Needle Guide545554552022-04-01
10841912107084Sterile Single-Use Probe Cover Kit264826482022-03-11
10841912107091Sterile Single-Use Surgical Probe Cover Kit269626962022-03-11
00841912107049Reusable Biopsy Bracket62962021-12-17
10841912107053General Purpose Probe Cover2323VPC55362021-12-17
00841912107070Biopsy Starter Kit72962021-12-17
00841912107018Biopsy Starter Kit72932021-10-22
00841912107032Multi-Angle Biopsy Starter Kit72942021-10-22
00841912106783Reusable Biopsy Bracket63062021-10-08
00841912106998Multi-Angle Biopsy Starter Kit73062021-10-08
00841912106981Multi Angle Biopsy Starter Kit73632021-09-30
20841912104714Probe Storage Covers11402021-09-20
10841912106971PullUp Sterile Single-Use Surgical Probe Cover Kit208720872021-07-30

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Primary DI, Brand, Company table
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00841517112561Sonosite PXFUJIFILM SONOSITE, INC.ITX2026-03-12
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04987670102769PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
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10885632426797HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11